BlogHeader.png

The Top Eight Most Asked Questions about Microbial In-Use Studies

According to Dr. John Metcalfe, “pharmaceutical companies go to great lengths to manufacture a drug product which is sterile, whether by terminal sterilization or aseptic processing. Equally important to the microbiological quality of the product at the time of product release is its microbiological quality at the time of patient administration.” This Q & A featuring microbial in-use studies with microbiological expert, Brent Harlow, will address the most common questions asked about these studies.

Topics: Analytical Testing Microbiology

White Paper: Insight into Orphan Drug Formulations and Regulations

The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that affects a population of fewer than 200,000 people. Rare diseases have various causes— most notably, genetics. However, the National Institutes of Health (NIH) states, “many rare diseases, including infections, some rare cancers, and some autoimmune diseases, are not inherited. While researchers are learning more each year, the exact cause of many rare diseases is still unknown” (NIH, 2017).

The term “orphan disease” resulted from pharmaceutical companies not having the resources to design and scale up formulations to treat these diseases, due to the lack of financial support for such highly specialized programs. The Orphan Drug Act (ODA) allows for the necessary financial backing of pharmaceutical companies to develop treatments for rare diseases (NIH, 2017), giving special status to a drug or biological product (drug) upon request of a sponsor. This status is referred to as orphan designation or orphan status.

Topics: Resource Center Oral Solid Dose Formulations Regulatory Compliance Orphan Drugs

Alcami Employee Recognized with Honor Flight

The nonprofit Honor Flight Network honors America’s military veterans for their sacrifices by transporting as many of them as possible to see the Washington, D.C. memorials of the wars they fought in, at no cost to them. Alcami employee and Vietnam veteran, Herman Anthony, was recently selected for an Honor Flight, and was accompanied by Milwaukee Brewers all-star relief pitcher, Corey Knebel. Herman received a hero’s welcome at the Milwaukee airport from Alcami colleagues, friends, family, and the general public. He recently spoke with Alcami's Marketing & Corporate Communications team to discuss his experience.

Topics: Company News Alcami in Action

Alcami President & CEO Elected as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association

Stephan Kutzer, Ph.D., President & CEO of Alcami Corporation, has been elected to serve as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association (DCAT) beginning November 1, 2018. Together with the ten other members of DCAT’s Board of Directors, Dr. Kutzer will help develop and guide the organization’s strategic plan in a manner to best serve the organization’s 500+ member companies.

Topics: Company News

Beyond the Label: Four Challenges to Serialization

Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a serialized label. These are, of course, very legitimate concerns. However, there are much more complex issues at hand, including the importance of standardization, scaling information technology infrastructure, agility to accommodate regulatory changes, and data security.

Why Serialization Matters
The first objective of any pharmaceutical company is to deliver safe and effective medicines to patients. While historically there have been methods to provide product visibility and control along the supply chain, the processes have been highly manual, with paper-based record keeping being the prevalent modality.

Topics: Regulatory Compliance Serialization Supply Chain

WEBINAR: Submitting Samples through Alcami OnDemand™

Join Alcami for a webinar to learn more about submitting samples through Alcami OnDemand, a customer portal that provides clients unprecedented and rapid access and visualization into ongoing projects. 

Using Alcami OnDemand to submit Analytical Testing projects is a simple process that will save you time and streamline project tracking. This webinar will detail the finer points of online sample submission. We will show you how to build a sample submission project in Alcami OnDemand and walk you through the following processes:

Topics: Webinars Analytical Development Analytical Testing Alcami OnDemand

SCIENTIST SPOTLIGHT: October 2018

Name: Zach Dubey
Alcami Site: Germantown, WI

How long have you been with Alcami?
I have been with Alcami for two years.

What is your role? 
I am a Process Chemist in the Kilo Labs Manufacturing department, which manufactures APIs, normally generics, on a smaller scale (gram to kilogram scale).

What is the most rewarding part of your job?
The most rewarding part of my job is training new personnel and collaborating with the Technical Services department on the Kilo Labs processes with which I have become intimately familiar. I also enjoy learning about these processes beyond the executional level (i.e. the sequence of steps in the batch record); understanding the underlying chemistry within these processes provides a greater respect for the chemistry and answers “the why question,” or why I am executing a step—or sequence of steps—a certain way. This has also been beneficial when writing complicated deviations that require a sophisticated understanding of these processes.

Topics: Alcami Voices

Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances

Controlled drug substances are scheduled based on medical use in treatment, potential for abuse, and dependence caused if abused— the lower the control schedule the more potential for abuse. The process to obtain approval from the Drug Enforcement Administration (DEA) for Schedule I-V controlled substances and List I chemicals licensing involves intricacy and a detailed timeline of approvals. This article will discuss the background of controlled substance applications and how to successfully work with the DEA.

Topics: Thought Leadership Regulatory Compliance Drug Product Controlled Substances API

Alcami Launches New Features and Enhancements to Alcami OnDemand

Alcami OnDemand™ is a customer-focused portal giving you the power to know where your results are at all times. Alcami OnDemand (AOD) features quoting tools, project tracking, material and test reference libraries, a progressive messaging center, and central file repository. AOD provides you with the ability to build a custom sample submission quote quickly and track major milestones within your project.

Alcami’s new features and enhancements to the platform allow for a more user-friendly and intuitive system. Our mission is to continuously bring first-to-market initiatives to the pharmaceutical and biotechnology industries— further increasing our commitment to our clients and their patients. Improved features include:

Topics: Alcami OnDemand Analytical Testing

Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH recently received U.S. Food and Drug Administration (FDA) approval of moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). MDGH utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical approval deadlines.

Topics: Company News Analytical Development Analytical Testing Development Drug Product